PHILADELPHIA, Oct. 16, 2022 (GLOBE NEWSWIRE) — Kaskela Law LLC announces that it is investigating CorMedix Inc. (“CorMedix” or the “Company”). CRMD on behalf of the company’s long-term investors.

An amended securities fraud complaint was recently filed against CorMedix on behalf of certain investors who purchased common stock of the Company between October 16, 2019 and September 6, 2021.

According to the complaint, during this period CorMedix and certain of the Company’s officers made a number of materially false and misleading statements about the Company’s business, operations and prospects to investors. Among other things, the Complaint alleges that the Defendants failed to disclose that (i) there were deficiencies in the facility used to manufacture DefenCath and/or in relation to the procedure for removing the labeled volume from the vials such that the fill volume was inconsistent was; (ii) DefenCath’s New Drug Application (“NDA”) reflected these deficiencies; and (iii) given the foregoing deficiencies, it was unlikely that the FDA would approve DefenCath’s NDA.

On March 1, 2021, CorMedix issued a press release announcing that it had received a Complete Response Letter (“CRL”) from the FDA. As detailed in the complaint, this press release revealed that the “FDA identified concerns at the third-party manufacturing facility after reviewing the records requested by the FDA and provided by the manufacturing facility.” As a result of this news, the company’s shares fell $5.98 per share, or 40%, on high trading volume to close at $9.02 per share on March 1, 2021.

Subsequently, on September 7, 2021, CorMedix announced that it was “encountering delays with its third-party provider [commercial manufacturing organization (“CMO”)]’ in relation to ‘issues unrelated to DefenCath’s manufacturing activities’ and that ‘the timeline for CorMedix and the CMO to address deficiencies at the facility required to resubmit the NDA for DefenCath is uncertain[.]”